TAG ARCHIVES FOR IRB

16
Mar2020

Pediatric subjects participating in HHS-funded or FDA-regulated studies are afforded additional protections not codified in subpart A of the Federal Policy for the Protection of Human Subjects (the Common Rule). On September 18, 2019, PRIM&R hosted a webinar, Pediatric Risk Determination: IRB Considerations and Cases. Presented by Rich Gormon, MD, and Donna L. Snyder, MD, this webinar helped attendees understand pediatric subpart D regulations, identify criteria for pediatric approvable research, and evaluate if the interventions or procedures in a protocol hold the prospect of direct benefit. After the webinar, the speakers responded to attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more

9
Mar2020

I was eager to attend the session "Reviewing Exercise Science Research at Primarily SBER Institutions" (speakers: Summer B. Cook, PhD; Michael Leary, PhD CIP; Meghan Felicia Pronovost, MS) during the 2019 Social, Behavioral, and Educational Research Conference (SBER19) specifically because of some of the research occurring at my institution. I was curious how our process stacked up with other institutions, and I had hopes of providing tips to improve research methods for our investigators/student researchers as well as the review and critical thinking practices of the IRB committee. I noticed a plethora of similarities and opportunities for advancement, as expected. As the session continued, I began to wonder how we as administrators balance the specificity of our application and approval process with the variation of protocols we review in our limited capacities. I thought to myself: what would it take to integrate a change in practice based on new education from SBER19? What is the added value of the change? How does it compare with the amount of work it would take to devise and implement the change? Read more

15
Jan2020

Conducting an Institutional Review Board (IRB) self-assessment may help administrators refine standard operating procedures and streamline communication. It’s an essential part of performance evaluation and provides an opportunity to celebrate achievements, conduct appraisals, and reflect upon past decisions. It also provides a thoughtful written review of established goals, competencies, and overall office performance. Read more

8
Jan2020

The risks associated with social, behavioral, and educational research (SBER) are often subjective, unpredictable, and hard-to-identify. Even the most experienced reviewers struggle with quantifying potential harms associated with SBER. On March 20, 2019, PRIM&R hosted a webinar, Assessing and Mitigating Risk in SBER. Presented by Amy Ben-Arieh, JD, MPH and Lara Sloboda, PhD, this webinar helped attendees understand risk as defined in the regulations and as applied to SBER; implement strategies for mitigating risk in SBER; and appreciate the complex nature of risk assessment and mitigation in SBER. Read more

11
Nov2019

Meet Sierra Verbockel, BS, MPA, who'll be covering the 2019 Social, Behavioral, and Educational Research and Advancing Ethical Research Conferences (SBER19/AER19) as a member of the Blog Squad. Members of PRIM&R's Conference Blog Squad provide an insider's view of the conferences by sharing their experience before, during, and after the meeting. Read more